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Showing 2951 - 3000Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients With Advanced NSCLC
On February 15, updated results were made available from the phase III JAVELIN Lung 200 trial comparing avelumab (Bavencio) to docetaxel in patients with unresectable, recurrent, or metastatic non–small cell lung cancer (NSCLC) whose disease progressed after treatment with a...
EXPERT POINT OF VIEW: Ann H. Partridge, MD, MPH, FASCO
“The simple questions are whether ovarian function suppression adds clinical benefit in premenopausal women, and is ovarian function suppression better with an aromatase inhibitor or tamoxifen,” said formal discussant of these trials, Ann H. Partridge, MD, MPH, FASCO, Professor of Medicine at...
Ovarian Function Suppression During and After Chemotherapy Valid for Some Patients With Early Breast Cancer
Temporary ovarian suppression during chemotherapy as a means of preserving ovarian function and fertility in young women with early breast cancer is controversial. An eagerly awaited meta-analysis including individual patient data from five randomized controlled trials found that the use of...
Perioperative Aromatase Inhibitors: No Effect on Recurrence, but Ki67 Level Important
Updated analysis from the United Kingdom’s POETIC trial found no evidence that perioperative aromatase inhibitor therapy slows or prevents time to recurrence of breast cancer. However, the study did show that tumor Ki67 levels after 2 weeks of perioperative aromatase inhibitor therapy are...
SABCS Highlights Focus on Predicting Residual Tumor Burden, Therapy-Related Arm Morbidity, Lifestyle and Cancer Risk
We have covered many of the important presentations from the 2017 San Antonio Breast Cancer Symposium in the pages of The ASCO Post and in our online Evening News. Here are summaries of additional noteworthy studies presented at the meeting. We hope you will find them of interest. Predicting...
Cabozantinib Improves Survival in Advanced Hepatocellular Carcinoma
Patients with previously treated advanced hepatocellular carcinoma derived a survival benefit from cabozantinib (Cabometyx), in the phase III CELESTIAL trial.1 “Cabozantinib represents a new treatment option for patients with advanced hepatocellular carcinoma after prior systemic anticancer...
2018 SURVIVORSHIP: Exercise Speeds Improvement in Arm Mobility After Surgery for Breast Cancer
New findings from a clinical trial of women with breast cancer suggest that guided exercise with a physical therapist after lymph node dissection helps women regain their range of arm motion more quickly. These findings will be presented by Paskett et al at the upcoming 2018 Cancer Survivorship...
2018 GU CANCERS SYMPOSIUM: Antiandrogenic Therapy in Nonmetastatic Castration-Resistant Prostate Cancer
Results from the phase III PROSPER trial in patients with nonmetastatic castration-resistant prostate cancer were presented by Hussain et al at the 2018 Genitourinary Cancers Symposium (Abstract 3). The results show that the use of enzalutamide (Xtandi) plus androgen-deprivation therapy (ADT)...
Avelumab in Advanced Urothelial Carcinoma: Further Study Needed to Clarify its Role
AS REVIEWED in this issue of The ASCO Post, Patel and colleagues have presented data from the phase I JAVELIN study evaluating avelumab (Bavencio) in platinum-refractory patients with advanced urothelial carcinoma.1 The drug is active with durable responses when compared with historical...
EXPERT POINT OF VIEW: Eric P. Winer, MD, FASCO; Heikki Joensuu, MD; and Julie Gralow, MD, FASCO
IN INTERVIEWS with The ASCO Post and in discussions held during the meeting, several breast cancer experts weighed in on the findings of GeparSepto and CALGB 40502. Eric P. Winer, MD, FASCO, Chief of the Division of Women’s Cancers and the Thompson Senior Investigator in Breast Cancer Research at ...
Updates of Key Studies Differ on Relative Benefit of Nab-Paclitaxel in Breast Cancer
TWO IMPORTANT STUDIES, both updates of earlier findings and presented at the 2017 San Antonio Breast Cancer Symposium, provided different findings as to the relative benefit of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane), vs solvent-based paclitaxel in breast cancer. “The two studies...
Adjuvant Zoledronic Acid in Early Breast Cancer: Is 5 Years Better?
THE PHASE III SUCCESS A trial, presented at the 2017 San Antonio Breast Cancer Symposium, found no benefit for extending the use of intravenous zoledronic acid from 2 years to 5 years.1 “At this time point, our study showed no difference in disease-free survival or overall survival between 5 years ...
Trastuzumab for 9 Weeks Fails to Show Noninferiority in HER2-Positive Breast Cancer
ANOTHER TRIAL has validated that 1 year of adjuvant trastuzumab (Herceptin) remains the standard in HER2-positive breast cancer, but the margin of difference, compared with just 9 weeks of the drug, was slim, based on the findings of the phase III SOLD trial reported at the 2017 San Antonio Breast...
For Patients Treated for Myeloma, Antibiotic Prophylaxis May Reduce Infections and Deaths
IN PATIENTS undergoing treatment of multiple myeloma, the prophylactic use of levofloxacin significantly reduced febrile episodes and deaths, without increasing healthcare-associated infections or carriage of key nosocomial pathogens, in a large multicenter study from the United Kingdom.1 The...
Ramucirumab/Chemotherapy in Gastric Cancer: ‘Positive’ Trial but Insufficient Benefit
BASED ON EFFICACY seen in the second-line setting for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma, ramucirumab (Cyramza) was evaluated as first-line therapy in the international phase III RAINFALL trial. Although the study met its primary endpoint, with a 25%...
EXPERT POINT OF VIEW: Zsofia Kinga Stadler, MD
DISCUSSANT ZSOFIA KINGA STADLER, MD, of Memorial Sloan Kettering Cancer Center, found the nivolumab (Opdivo)/ipilimumab (Yervoy) combination results very encouraging but was also impressed with the monotherapy arm. Both approaches are significant advances in treatment, she said. “The treatment of ...
Nivolumab Plus Ipilimumab Improves Outcomes in Metastatic Colorectal Cancer
IN THE FIRST REPORT of the full cohort of CheckMate-142, nivolumab (Opdivo) plus ipilimumab (Yervoy) led to a 1-year overall survival rate of 85% in previously treated patients with metastatic colorectal cancer who have DNA mismatch repair–deficient (dMMR) or microsatellite instability–high...
FDA Approves Radiopharmaceutical for Rare Gastrointestinal Cancers
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The drug is indicated for adult patients with somatostatin receptor–positive GEP-NETs. GEP-NETs can be...
The Toxicity of Time
The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA
On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...
Blinatumomab in Relapsed or Refractory B-Cell Precursor ALL
On July 11, 2017, blinatumomab (Blincyto) was approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.1,2 Blinatumomab received accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative...
FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting
On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...
Israel Cancer Research Fund Appoints National Executive Director
Mark A. Israel, MD, a pediatric oncologist, translational scientist, and a recognized leader in cancer research has been appointed National Executive Director of the Israel Cancer Research Fund (ICRF), a nonprofit organization dedicated solely to funding cancer research in Israel. Dr. Israel joins ...
Against All Odds
The days leading up to our daughter Emily’s diagnosis of acute lymphoblastic leukemia (ALL) on May 28, 2010, when she was just 5, offered few clues about the terrifying, life-and-death months and years we were about to experience. She was happy and seemingly healthy, literally until the day before...
2018 GI CANCERS SYMPOSIUM: Nivolumab Plus Ipilimumab Yields Survival Benefit in Metastatic Colorectal Cancer
Nivolumab (Opdivo) plus ipilimumab (Yervoy) led to a 1-year overall survival rate of 85% in previously treated metastatic colorectal cancer patients with DNA mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) tumors. These data were presented in the first report ...
Pomegranates and Other Polyphenols: New Evidence to Share With Prostate Cancer Patients
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Channing Paller, MD, explores the role of pomegranate- and grape-based...
2018 GI CANCERS SYMPOSIUM: First-Line Lenvatinib vs Sorafenib in Unresectable Hepatocellular Carcinoma
The results of an analysis of the phase III REFLECT trial of lenvatinib mesylate (Lenvima) vs sorafenib (Nexavar) as first-line treatment for unresectable hepatocellular carcinoma based on independent imaging review were presented during the 2018 Gastrointestinal (GI) Cancers Symposium (Abstract...
2018 GI CANCERS SYMPOSIUM: Novel Triplet Combination Improves Progression-Free Survival in Patients With BRAF-Mutant Colorectal Cancer
Updated results were recently reported from the 30 patient safety lead-in of the phase III BEACON CRC trial evaluating the triplet combination of encorafenib (a BRAF inhibitor), binimetinib (an MEK inhibitor), and cetuximab (Erbitux, an anti–EGFR antibody) in patients with BRAF-mutant...
Pembrolizumab in Advanced Urothelial Carcinoma
On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
2018 GI CANCERS SYMPOSIUM: First-Line Ramucirumab in Gastric Cancer Improves Progression-Free but Not Overall Survival
The monoclonal antibody ramucirumab (Cyramza) was evaluated as first-line therapy for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma in the international phase III RAINFALL trial. Charles Fuchs, MD, of Yale New Haven Health in Connecticut, presented findings...
2018 GI CANCERS SYMPOSIUM: Cabozantinib Demonstrates Significant Overall Survival Benefit in Patients With Previously Treated Advanced HCC
Detailed results of the phase III CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) were presented in a late-breaking oral session by Abou-Alfa et al at the 2018 ASCO Gastrointestinal (GI) Cancers Symposium (Abstract 207). Study Findings In CELESTIAL,...
Venetoclax Plus Rituximab Outperforms Standard Bendamustine Plus Rituximab in CLL
Venetoclax (Venclexta) plus rituximab (Rituxan)—a non–chemotherapy-containing regimen—was superior to standard-of-care bendamustine plus rituximab for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to a final analysis of the phase III MURANO study reported at...
Carfilzomib-Based Treatment and Transplant in Smoldering Myeloma
Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...
Study Findings on Novel Therapies for Hematologic Malignancies
Here is an update on five different studies featured at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics center on possible newer treatment regimens in both Hodgkin and Burkitt lymphomas, relapsed or refractory chronic lymphocytic leukemia, and newly...
Power of Pathologic Complete Response to Neoadjuvant Therapy Demonstrated in I-SPY 2 Trial
More evidence of the power of pathologic complete response (pCR) now comes from an update of the multicenter, adaptively randomized I-SPY 2 trial. In a study reported at the 2017 San Antonio Breast Cancer Symposium, pCR predicted for event-free and distant disease–free survival in high-risk...
NSABP B-47: No Benefit for Adjuvant Trastuzumab in HER2-Low Breast Cancer
For more than a decade, breast cancer experts have wondered whether women with low levels of HER2 might derive some benefit from trastuzumab (Herceptin), based on signals seen in earlier trastuzumab trials. Most notably, in the landmark National Surgical Adjuvant Breast and Bowel Project (NSABP) ...
Presurgical Targeted Therapy Delays Relapse of High-Risk Stage III Melanoma
A pair of targeted therapies given before and after surgery for melanoma produced at least a sixfold increase in time to progression compared to standard-of-care surgery for patients with stage III disease, Amaria et al reported in The Lancet Oncology. Patients who had no sign of disease at surgery ...
ECHELON-1: A Commendable Study, but Questions Remain
“The important thing is not to stop questioning. Curiosity has its own reason for existing.” —Albert Einstein The phase III international ECHELON-1 study, designed to evaluate brentuximab vedotin (Adcetris) as part of a front-line chemotherapy regimen for previously untreated advanced classic...
Novel Antibody-Drug Conjugate Active in Refractory Triple-Negative Breast Cancer
In relapsed or refractory triple-negative breast cancer, the antibody-drug conjugate sacituzumab govitecan (IMMU-132) demonstrated significant clinical activity in an open-label study presented at the 2017 San Antonio Breast Cancer Symposium.1 “Metastatic triple-negative breast cancer is an...
Improved Overall and Progression-Free Survival With First-Line Pembrolizumab in Combination With Pemetrexed and Cisplatin or Carboplatin in NSCLC
The phase III KEYNOTE-189 trial—investigating pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)—met its dual primary endpoints of...
FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...
FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma
On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...
FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
Is Medical Assistance in Dying Compassionate Care?
Suicidal ideation while receiving end-of-life cancer care is not unusual but can often be reversed by palliative and psychosocial oncology interventions. That said, there are patients who, even after intensive interventions, request medical assistance in dying. Physician-assisted death has been a...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Approval was based on data from an open-label,...
Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
FDA Helps Streamline Approval Process for Supplemental Drug Indications
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
Neratinib Is Approved: Should We Reject It Anyway?
The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was...
Exercise Counteracts Fatigue, Pain in Women With Advanced Breast Cancer
A SUPERVISED and individualized exercise program can reduce fatigue and pain while improving cardiovascular health and quality of life in women being treated for advanced breast cancer, according to research presented by Eduardo Oliveira, PhD, Professor of Exercise Physiology and Exercise Cancer...
